K162952 is an FDA 510(k) clearance for the C.T.M. Mobility Scooter. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Chien TI Enterprise Co., Ltd. (New Taipei City, Hsin Chuang District, TW). The FDA issued a Cleared decision on May 3, 2017, 191 days after receiving the submission on October 24, 2016.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K162952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2016 |
| Decision Date | May 03, 2017 |
| Days to Decision | 191 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | INI - Vehicle, Motorized 3-wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3800 |